Perindopril

Leaflet attached to the packaging: patient information

Perindopril, 2 mg, tablets

Perindopril, 4 mg, tablets

tert-Butylamine perindopril

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Perindopril and what is it used for
• 2. Important information before taking Perindopril
• 3. How to take Perindopril
• 4. Possible side effects
• 5. How to store Perindopril
• 6. Contents of the packaging and other information

1. What is Perindopril and what is it used for

The active substance of Perindopril tablets belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Perindopril tablets are used:

• to treat high blood pressure (hypertension),
• to treat symptomatic heart failure (a condition in which the heart is not able to pump enough blood to meet the body's needs),
• to reduce the risk of heart events, such as heart attack, in patients with stable coronary artery disease (a condition in which blood flow to the heart is reduced or blocked) and in patients who have had a heart attack and/or a procedure to improve blood flow to the heart, by widening the blood vessels that supply the heart with blood.

2. Important information before taking Perindopril

When not to take Perindopril

• if the patient is allergic to perindopril, any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had a reaction of hypersensitivity with sudden swelling of the face, lips, tongue, or throat, or difficulty swallowing or breathing (angioedema) after taking an ACE inhibitor;
• if the patient has had angioedema or has a family history of angioedema;
• after the third month of pregnancy (it is also recommended to avoid taking Perindopril during early pregnancy - see section "Pregnancy");
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren;
• if the patient is undergoing dialysis or blood filtration using a method other than hemofiltration or ultrafiltration. Depending on the device used, perindopril may not be suitable for the patient.
• if the patient has kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.

Warnings and precautions

Before starting to take Perindopril, the patient should discuss it with their doctor or pharmacist.
It may turn out that Perindopril is not suitable for the patient, or that regular monitoring of the patient's health is necessary. Therefore, before starting to take the medicine, the patient should inform their doctor about the following conditions:

• reduced or blocked blood flow through the heart (stable coronary artery disease);
• enlargement of the heart muscle or problems with the heart valves;
• narrowing of the artery that supplies blood to the kidneys (renal artery stenosis);
• the patient has abnormally high levels of a hormone called aldosterone in their blood (primary aldosteronism);
• diabetes;
• kidney, liver, or heart disease;
• dialysis treatment or recent kidney transplant;
• following a low-salt diet, severe vomiting, or diarrhea, or taking medicines that increase urine production (diuretics);
• taking lithium, medicines used to treat mania or depression;
• taking potassium supplements or salt substitutes containing potassium, or other medicines that may increase potassium levels in the blood, such as heparin;
• the patient will undergo a procedure to remove cholesterol from the body using a special device (LDL apheresis);
• the patient will undergo or is undergoing desensitization treatment for bee or wasp stings (allergy shots);
• the patient has collagen disease, such as systemic lupus erythematosus or scleroderma;
• the patient is taking immunosuppressive medicines;
• the patient's blood pressure is not well controlled due to their race (this applies especially to black patients);
• the patient will undergo surgery or general anesthesia;
• the patient has cerebrovascular disease;
• if the patient is taking any of the following medicines, the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) may increase:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent transplant rejection and to treat cancer (e.g., sirolimus, everolimus, temsirolimus),
• wildagliptin, a medicine used to treat diabetes.
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor blockers (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
• aliskiren.

Angioedema
Patients treated with ACE inhibitors, including Perindopril, have reported angioedema (a severe allergic reaction; symptoms include swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing). This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Perindopril and contact their doctor immediately. See also section 4.
The patient must tell their doctor if they think they are (or may be) pregnant. Perindopril is not recommended during early pregnancy and should not be taken if the patient is pregnant after the third month, as it may cause serious harm to the baby if taken in this condition (see section on pregnancy).

Children and adolescents

The use of perindopril in children and adolescents under 18 years of age is not recommended.

Perindopril and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
The patient should not take medicines available without a prescription without consulting their doctor. This applies especially to:

• cold medicines containing pseudoephedrine or phenylephrine as the active substance;
• painkillers, including aspirin (a substance found in many medicines used to reduce pain and fever, as well as to prevent blood clots);
• potassium supplements;
• salt substitutes containing potassium.

The patient should inform their doctor about taking any of the following medicines to ensure that it is safe to take Perindopril:

• other medicines used to treat high blood pressure and/or heart failure, including diuretics,
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; cyclosporine or tacrolimus, an immunosuppressive medicine used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots),
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day,
• medicines used to treat irregular heartbeat (procainamide),
• medicines used to treat diabetes (insulin or oral antidiabetic medicines like wildagliptin),
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis),
• medicines used to treat gout (allopurinol),
• non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, diclofenac, including aspirin used as a painkiller,
• vasodilators, including nitrates,
• estramustine (used to treat cancer),
• medicines that stimulate certain parts of the nervous system, such as ephedrine, noradrenaline, or adrenaline (sympathomimetics),
• medicines used to treat mania or depression (lithium),
• medicines used to treat mental illnesses, such as depression, anxiety, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotic medicines),
• gold salts for injection used to treat arthritis (sodium aurothiomalate),
• medicines used to treat diarrhea (racecadotril) or medicines used to prevent transplant rejection (sirolimus, everolimus, temsirolimus, or other mTOR inhibitors). See section "Warnings and precautions".

The doctor may need to adjust the dose and/or take other precautions:

• if the patient is taking an angiotensin receptor blocker (ARB) or aliskiren (see also the information under the heading "When not to take Perindopril" and "Warnings and precautions").

Taking Perindopril with food, drink, and alcohol

It is recommended to take Perindopril before meals to reduce the effect of food on the way the medicine works.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor about a suspected (or planned) pregnancy. The doctor will usually recommend stopping Perindopril before a planned pregnancy or as soon as possible after confirming pregnancy, and will recommend taking a different medicine instead of Perindopril. Perindopril is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to the baby if taken in this condition (see section on pregnancy).
Breastfeeding
The patient should inform their doctor about breastfeeding or planning to breastfeed. Perindopril is not recommended during breastfeeding, especially in newborns or premature babies. The doctor may recommend a different medicine.

Driving and using machines

Perindopril usually does not affect alertness, but some patients may experience dizziness or weakness due to low blood pressure. Therefore, the ability to drive or operate machines may be impaired.

Perindopril contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Perindopril

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The usual dose for treating high blood pressure is 4 mg of perindopril (1 tablet of 4 mg Perindopril) once a day. If necessary, the dose may be increased to 8 mg of perindopril (2 tablets of 4 mg Perindopril) once a day.
The usual dose for treating symptomatic heart failure is 2 mg of perindopril (1 tablet of 2 mg Perindopril) once a day; if necessary, the dose may be increased to 4 mg of perindopril (1 tablet of 4 mg Perindopril) once a day.
The usual dose for treating stable coronary artery disease is 4 mg of perindopril (1 tablet of 4 mg Perindopril) once a day; if necessary, the dose may be increased to 8 mg of perindopril (2 tablets of 4 mg Perindopril) once a day.
The tablets should be taken with a glass of water, preferably at the same time every day, in the morning, before breakfast.
Depending on the treatment results, the doctor will adjust the dosage individually for the patient.
The dosage may be lower than usual, depending on the doctor's decision: for elderly patients, patients with kidney problems, patients with high blood pressure caused by narrowing of the artery that supplies blood to the kidneys (renal artery stenosis), patients taking diuretics, patients with uncontrolled high blood pressure who cannot stop taking diuretics, patients with severe heart failure, and patients taking vasodilators.
The duration of treatment will be determined by the doctor based on the patient's health condition.
Use in children and adolescents
The efficacy and safety of perindopril in children have not been established. Therefore, it is not recommended to give it to this age group.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Perindopril than recommended

In case of taking too many tablets, the patient should immediately consult their doctor or pharmacist.
The most likely symptom of overdose is a sudden drop in blood pressure (hypotension). Other symptoms may include: rapid or slow heartbeat, unpleasant feeling of irregular or stronger than usual heartbeat, increased frequency and depth of breathing, dizziness, anxiety, and cough.
In case of significant drop in blood pressure, the patient should lie down, support their legs so that they are elevated in relation to the body, and put only a flat pillow under their head.

Missing a dose of Perindopril

It is important to take the medicine every day. However, if the patient forgets to take one dose, they should simply continue taking the medicine from the next dose in the usual way. The patient should not take a double dose to make up for the missed dose. If the patient misses more than one dose, they should take the next dose as soon as possible and then continue taking the medicine as prescribed.

Stopping Perindopril treatment

If the patient stops taking the medicine, their blood pressure may rise again, which may increase the risk of complications related to high blood pressure, especially in the heart, brain, and kidneys.
The condition of patients with heart failure may worsen to the point where hospitalization is necessary. Therefore, if the patient is considering stopping Perindopril, they should first discuss it with their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Perindopril can cause side effects, although not everybody gets them.

The patient should stop taking Perindopril and contact their doctor immediately if they experience any of the following serious side effects:

including the following:which can be serious:

• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema; see section 2 "Warnings and precautions") (uncommon - may affect up to 1 in 100 people);
• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people);
• very rapid or irregular heartbeat, chest pain (angina pectoris), or heart attack (very rare - may affect up to 1 in 10,000 people);
• weakness of the arms or legs, or difficulty speaking, which may be a sign of a stroke (very rare - may affect up to 1 in 10,000 people);
• sudden wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm; uncommon - may affect up to 1 in 100 people);
• pancreatitis, which can cause severe abdominal pain and very poor general condition (very rare - may affect up to 1 in 10,000 people);
• yellowing of the skin or eyes (jaundice), which can be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people);
• rash, often starting with the appearance of red, itchy spots on the face, arms, or legs (erythema multiforme; very rare - may affect up to 1 in 10,000 people).

The patient should inform their doctor if they experience any of the following side effects:

Common side effects (may affect up to 1 in 10 people):

• headache, dizziness, feeling of spinning (vertigo), feeling of tingling or numbness in the hands or feet (paresthesia),
• vision disturbances,
• ringing, buzzing, hissing, clicking in the ears (tinnitus),
• low blood pressure (hypotension) and symptoms related to hypotension,
• cough, shortness of breath (dyspnea),
• nausea, vomiting, abdominal pain, taste disturbances, indigestion, diarrhea, and constipation,
• rash, itching,
• muscle cramps,
• weakness.

Uncommon side effects (may affect up to 1 in 100 people):

• hypoglycemia (very low blood sugar),
• high potassium levels in the blood, which may be temporary and resolve after stopping treatment,
• low sodium levels,
• mood disturbances, sleep disturbances,
• depression,
• drowsiness, fainting,
• rapid heartbeat, palpitations,
• vasculitis (inflammation of blood vessels),
• wheezing (bronchospasm),
• dryness of the mucous membranes of the mouth,
• hypersensitivity reaction with sudden swelling of the face, neck, lips, mucous membranes, tongue, or throat (with hoarseness or difficulty breathing), possibly also swelling of the hands and feet (angioedema), hives,
• excessive sweating,
• hypersensitivity to light (increased skin sensitivity to sunlight), pemphigoid (an autoimmune skin disease, its symptoms include large, tense blisters),
• joint pain, muscle pain,
• kidney problems,
• impotence (inability to achieve or maintain an erection),
• chest pain, poor general condition, peripheral edema, fever,
• increased levels of urea and creatinine in the blood,
• falls.

Rare side effects (may affect up to 1 in 1,000 people):

• worsening of psoriasis,
• abnormal laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood,
• worsening of psoriasis,
• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion),
• reduced or absent urine production,
• sudden flushing of the face and neck,
• acute kidney failure.

Very rare side effects (may affect up to 1 in 10,000 people):

• decreased hemoglobin and hematocrit values, thrombocytopenia, leukopenia/neutropenia, agranulocytosis, or pancytopenia. Hemolytic anemia in patients with a congenital deficiency of glucose-6-phosphate dehydrogenase,
• disorientation,
• arrhythmias (abnormal heart rhythms), chest pain (angina pectoris), heart attack, and stroke, probably secondary to excessive blood pressure lowering in patients at high risk,
• pulmonary infiltrates with eosinophilia (a type of white blood cell), eosinophilic pneumonia (inflammation of the lungs with eosinophilia),
• pancreatitis,
• hepatitis,
• erythema multiforme (a rash with red, flat spots).

Frequency not known (frequency cannot be estimated from the available data):

• blue discoloration, numbness, and pain in the fingers or toes (Raynaud's phenomenon).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Perindopril

The medicine should be stored out of sight and reach of children.
Store in the original packaging.
Store at a temperature not exceeding 30°C.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Perindopril contains

• The active substance of Perindopril is perindopril tert-butylamine. Perindopril, 2 mg and 4 mg tablets:Each tablet contains 2 mg or 4 mg of perindopril tert-butylamine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium bicarbonate, anhydrous colloidal silica, magnesium stearate. See section 2 "Perindopril contains lactose".

What Perindopril looks like and contents of the pack

2 mg tablets are white, round, biconvex.
4 mg tablets are white, oval, biconvex with beveled edges and a score line on one side.
Available in packs of:
30, 60, or 90 tablets in blisters, in a cardboard box

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. +48 22 57 37 500

Date of last revision of the leaflet: